Study identification

PURI

https://redirect.ema.europa.eu/resource/32544

EU PAS number

EUPAS17410

Study ID

32544

Official title and acronym

Clinical Characteristics of The First IMLYGIC™ Patients With Unresectable Stage IIIB-IVM1a Melanoma Treated in Routine Clinical Practice, in Selected European Countries (20140413)

DARWIN EU® study

No

Study countries

Austria
Germany
Netherlands
United Kingdom

Study description

The treatment landscape for melanoma (including targeted and immunotherapies) continues to evolve rapidly. There is a lack of availabledata outside of the clinical trial setting in relation to the patient, disease and treatment characteristics of patients who are prescribed IMLYGICTM as melanoma therapy, and the respective physician’s prescribing behaviour and rationale. Real-world data is thus warranted to inform on usual care practice with regards to IMLYGICTM use for the treatment of adults with unresectable metastatic melanoma. The purpose of this study is to collect data on the first EU patients receiving IMLYGICTM in a real world setting.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution
Multiple centres: 9 centres are involved in the study

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol

01.02.05 Special Protocol Ver 1.0 2016-10-28 English

English (451.13 KB - PDF)View document
Updated protocol

20140413 01.02.06 Public Redacted Protocol Ver 1.0 English

English (227.41 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable